Wound dressing comprising a monitor interface

ABSTRACT

A wound dressing and a monitor device is disclosed, the wound dressing comprising a top layer; a first adhesive layer with a proximal surface configured for attachment of the wound dressing to the skin surface of a user; an absorbent core layer; an electrode assembly comprising a plurality of electrodes arranged on a distal side of the absorbent core layer; and a monitor interface configured for connecting the wound dressing to a monitor device, the monitor interface comprising a plurality of terminals configured to form electrical connections with respective terminals of the monitor device, wherein the wound dressing comprises a flexible element, the flexible element being bendable and/or twistable between a first flexible element end and a second flexible element end, and wherein the monitor interface comprises a coupling part positioned at the first flexible element end.

The present disclosure relates to wound dressings and in particular towound dressings with a monitor interface and sensing capability tofacilitate monitoring of the wound/wound dressing during use of thewound dressing. Methods of manufacturing a wound dressing and methodsfor monitoring a wound dressing are also disclosed together with wounddressing system, and devices of the wound dressing system. The wounddressing system comprises a wound dressing and a monitor device. Inparticular, the present disclosure relates to a wound dressingcomprising a monitor interface for enabling or facilitating monitoringthe operation state or condition of the wound dressing.

BRIEF DESCRIPTION OF THE DRAWING

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated into and a part ofthis specification. The drawings illustrate embodiments and togetherwith the description serve to explain principles of embodiments. Otherembodiments and many of the intended advantages of embodiments will bereadily appreciated as they become better understood by reference to thefollowing detailed description. The elements of the drawings are notnecessarily to scale relative to each other. Like reference numeralsdesignate corresponding similar parts.

FIG. 1 illustrates an exemplary wound dressing system,

FIG. 2 illustrates an exemplary monitor device of the wound dressingsystem,

FIG. 3 is a proximal view of a first adhesive layer of a wound dressing,

FIG. 4 is a schematic cross-section of an exemplary wound dressing,

FIG. 5 is a proximal view of an exemplary electrode assembly,

FIG. 6 is more detailed proximal view of a part of exemplary electrodeassembly of FIG. 5,

FIG. 7 is a schematic cross-section of an exemplary wound dressing,

FIG. 8 is a proximal view of an exemplary first support layer,

FIG. 9 is a proximal view of an exemplary first masking layer,

FIG. 10 is a proximal view of an exemplary second support layer,

FIG. 11 is a proximal view of an exemplary second masking layer,

FIG. 12 is a distal view of an exemplary second support layer,

FIG. 13 is a proximal view of an exemplary second masking layer,

FIG. 14 is a distal view of an exemplary first support layer,

FIG. 15 is a schematic cross-section of a part of a wound dressing,

FIG. 16 is a distal view of an exemplary wound dressing,

FIG. 17 is a schematic cross-section of a part of a wound dressing,

FIG. 18 is a distal view of an exemplary wound dressing,

FIG. 19 is a schematic cross-section of a part of a wound dressing,

FIG. 20 is a distal view of an exemplary wound dressing, and

FIG. 21 is a perspective view of a wound dressing and a monitor device.

DETAILED DESCRIPTION

Various exemplary embodiments and details are described hereinafter,with reference to the figures when relevant. It should be noted that thefigures may or may not be drawn to scale and that elements of similarstructures or functions are represented by like reference numeralsthroughout the figures. It should also be noted that the figures areonly intended to facilitate the description of the embodiments. They arenot intended as an exhaustive description of the invention or as alimitation on the scope of the invention. In addition, an illustratedembodiment needs not have all the aspects or advantages shown. An aspector an advantage described in conjunction with a particular embodiment isnot necessarily limited to that embodiment and can be practiced in anyother embodiments even if not so illustrated, or if not so explicitlydescribed.

In the following, whenever referring to proximal side or surface of alayer, an element, a device or part of a device, the referral is to theskin-facing side or surface, when a user wears the wound dressing.Likewise, whenever referring to the distal side or surface of a layer,an element, a device or part of a device, the referral is to the side orsurface facing away from the skin, when a user wears the wound dressing.In other words, the proximal side or surface is the side or surfaceclosest to the user, when the wound dressing is fitted on a user and thedistal side is the opposite side or surface—the side or surface furthestaway from the user in use.

The axial direction is defined as the direction away from the skinsurface of the user, when a user wears the wound dressing. Thus, theaxial direction is generally perpendicular to the skin or abdominalsurface of the user.

The radial direction is defined as perpendicular to the axial direction.In some sentences, the words “inner” and “outer” may be used. Thesequalifiers should generally be perceived with respect to the radialdirection, such that a reference to an “outer” element means that theelement is farther away from a centre portion of the wound dressing thanan element referenced as “inner”. In addition, “innermost” should beinterpreted as the portion of a component forming a centre of thecomponent and/or being adjacent to the centre of the component. Inanalogy, “outermost” should be interpreted as a portion of a componentforming an outer edge or outer contour of a component and/or beingadjacent to that outer edge or outer contour.

The use of the word “substantially” as a qualifier to certain featuresor effects in this disclosure is intended to simply mean that anydeviations are within tolerances that would normally be expected by theskilled person in the relevant field.

The use of the word “generally” as a qualifier to certain features oreffects in this disclosure is intended to simply mean—for a structuralfeature: that a majority or major portion of such feature exhibits thecharacteristic in question, and—for a functional feature or an effect:that a majority of outcomes involving the characteristic provide theeffect, but that exceptionally outcomes do no provide the effect.

The present disclosure relates to a wound dressing system and devicesthereof, such as a wound dressing, a monitor device, and optionally oneor more accessory devices. Further, methods related to an accessorydevice of the wound dressing system and accessory devices thereof aredisclosed. An accessory device (also referred to as an external device)may be a mobile phone or other handheld device. An accessory device maybe a personal electronic device, e.g. a wearable, such as a watch orother wrist-worn electronic device. An accessory device may be a dockingstation. The docking station may be configured to electrically and/ormechanically couple the monitor device to the docking station. Thedocking station may be configured for charging the monitor device and/orconfigured for transferring data between the monitor device and thedocking station. The wound dressing system may comprise a server device.The server device may be operated and/or controlled by the wounddressing system manufacturer and/or a service centre.

A wound dressing system comprising a wound dressing and/or a monitordevice is disclosed, wherein the monitor device is a monitor device asdescribed herein.

The present disclosure provides a wound dressing system and devicesthereof, such as a wound dressing, a monitor device, and optionally oneor more accessory devices which either alone or together facilitatereliable monitoring of the wound dressing and operating state thereof.Accordingly, the wound dressing system and devices thereof enableproviding information to the user about the operating state of the wounddressing, and in turn optionally enable providing an indication to theuser or a caretaker of the remaining time frame for replacing the wounddressing without experiencing leakage and/or to provide optimum woundhealing conditions. Further, the wound dressing system and devicesthereof either alone or together facilitate reliable determination ofthe nature, severity and rapidness of exudate or other liquids wettingthe absorbent core layer of the wound dressing. Depending on the degreeof wetting and/or nature of the pattern of wetting propagation in theabsorbent core layer, the wound dressing system and devices thereofenable determination and provision of an indication to theuser/caretaker of the internal state of the wound dressing.

A wound dressing is disclosed, the wound dressing comprising a toplayer, a first adhesive layer with a proximal surface configured forattachment of the wound dressing to the skin surface of a user; anabsorbent core layer; and an electrode assembly comprising a pluralityof electrodes optionally arranged on a distal side of the absorbent corelayer. The top layer is optionally on a distal side of the electrodeassembly. The wound dressing may comprise a monitor interface.

It is an advantage of the present disclosure that an optimum or improveduse of a wound dressing is enabled and facilitated. In particular, thepresent disclosure facilitates that a wound dressing is not changed tooearly (leading to increased costs and/or material waste) nor too late(leading to adhesive failure, leakage and/or unsatisfactory woundhealing conditions). Accordingly, the user or a health care professionalis able to monitor and plan the use of the wound dressing. A relativelysimple wound dressing, i.e. optionally without more complex electricalcircuits, is provided, in turn providing a relatively cheap anddisposable wound dressing.

Further, determination of moisture or wetting pattern types andclassification of operating states of the wound dressing is useful inhelping to reduce the risk of a user experiencing leakage from a wounddressing and/or in helping reduce the risk of unsatisfactory woundhealing conditions. The present disclosure provides a simple, efficient,and easy-to-use wound dressing system with a high degree of comfort fora user.

The wound dressing comprises a first adhesive layer having a proximalsurface configured for attachment of the wound dressing to the skinsurface of a user. The first adhesive layer may comprise or be made of afirst composition. The first composition may comprise silicone. Thefirst adhesive layer may comprise a support layer with an adhesivematerial made of a first composition molded onto or otherwise attachedto the support layer. The first composition may be a thermoset, curableadhesive material. An example of such adhesive material may be asilicone based adhesive material. The first composition may be atwo-component system. Preferably, the first composition contains nosolvent. Preferred first compositions include polyurethane, acrylic,silicone or polyethylene or polypropylene oxide based cross-linkingtypes, e.g. as described in WO 2005/032401. The first composition may bea hotmelt type, which initially is heated to flow and subsequentlycooled to gel or crosslink. Instead of curing upon cooling, the firstcomposition may in some embodiments cure upon application of thermalenergy.

The support layer of the first adhesive layer may be any suitable layerbeing water impermeable but vapour permeable. A suitable support layermay be a polyurethane film.

The first adhesive layer may have perforations or through-going openingsarranged within an absorbing region, e.g. for allowing exudate from thewound to pass or flow through the perforations of the first adhesivelayer to be absorbed by absorbent core layer arranged on the distal sideof the first adhesive layer.

The perforations of the first adhesive layer may be made by punching,cutting or by applying high frequency mechanical vibrations, for exampleas disclosed in WO 2010/061228. The perforations may be arranged in aregular or random array, typically separated by 0.5 mm to 10 mm. Thenumber of holes per cm² may be between 1 and 100, such as between 1 and50 or even between 2 and 20. The perforations of the first adhesivelayer may have a diameter in the range from 0.5 mm to 10 mm, such as inthe range from 1 mm to 8 mm. In one or more exemplary wound dressings,the perforations of the first adhesive layer have a diameter in therange from 1 mm to 5 mm, e.g. from 1.5 mm to 5 mm, and even in the rangefrom 2 mm to 4 mm.

The wound dressing comprises an absorbent core layer also denoted anabsorbent pad. The absorbent core layer may be a uniform material or itmay be a composite, for example in the form of a layered constructioncomprising layers of different texture and properties. The absorbentcore layer may comprise foam, cellulose, super absorbent particlesand/or fibres. The absorbent core layer may comprise a layer of foamfacing the wound.

The absorbent core layer may comprise a polyurethane foam. The absorbentcore layer may comprise a super absorbing layer.

The absorbent core layer and/or the first adhesive layer may containactive ingredients, such as ibuprofen, paracetamol, silver compounds orother medically active ingredients configured to reduce pain and/or toimprove the healing of a wound. In one or more exemplary wounddressings, the absorbent core layer comprises a silver compound withantimicrobial properties.

The wound dressing comprises a top layer also denoted a backing layer.The top layer may be any suitable layer being water impermeable butvapour permeable. A suitable top layer may be a polyurethane film. Thetop layer is a protective layer protecting the absorbent core layer andother parts of the wound dressing from external strains and stress whenthe user wears the wound dressing. The electrodes, e.g. some or all theelectrodes, may be arranged between the first adhesive layer and the toplayer. The top layer may have a thickness in the range from 0.01 mm to1.0 mm, e.g. in the range from 0.02 mm to 0.2 mm, such as 0.04 mm.

The top layer may comprise a top layer opening configured to allow forconnection between the plurality of electrodes of the electrode assemblyand terminals of a monitor device coupled to the wound dressing. Forexample, the top layer opening may allow for a first part of theelectrode assembly to extend through the top layer to form a part of themonitor interface of the wound dressing.

The wound dressing may comprise a release liner, such as a one-piece,two-piece or a three-piece release liner. The release liner is aprotective layer that protects adhesive layer(s) during transport andstorage and is peeled off by the user prior to applying the wounddressing on the skin.

The electrode assembly comprises a plurality of sensor points or sensorzones distributed along a distal surface or distal side of the absorbentcore layer. During use of the wound dressing, exudate from the wound maywet the distal surface of the absorbent core layer and in turnshort-circuit an electrode pair of respective sensor points. Thus,wetting of a sensor point can be detected by determining the resistanceand/or other electronic characteristic, such as capacitance, between twoelectrodes (sensing parts) of the sensor point.

The plurality of electrodes optionally comprises a first set of firstelectrodes and optionally a second set of second electrodes, wherein asensing part of a first electrode and a sensing part of the secondelectrode may form a sensor point. The electrodes are electricallyconductive and may comprise one or more of metallic (e.g. silver,copper, gold, titanium, aluminium, stainless steel), ceramic (e.g. ITO),polymeric (e.g. PEDOT, PANI, PPy), and carbonaceous (e.g. carbon black,carbon nanotube, carbon fibre, graphene, graphite) materials. Anelectrode comprises a connection part, e.g. to form a terminal of themonitor interface or for connecting the respective electrode to othercomponents and/or to interface terminals/terminal elements. An electrodemay comprise one or more conductor parts and/or one or more sensingparts.

A set of electrodes, such as the first set of electrodes and/or thesecond set of electrodes, may comprise one or a plurality of electrodes.In one or more exemplary electrode assemblies, a set of electrodes, suchas the first set of electrodes and/or the second set of electrodes, maycomprise one, two, three, four, five, or more electrodes. In one or moreexemplary electrode assemblies, a first electrode of the first set offirst electrodes forms a part of a first sensor point and a secondsensor point of the plurality of sensor points. In one or more exemplaryelectrode assemblies, a first electrode of the first set of firstelectrodes forms a part of at least two sensor points, such as at leastthree sensor points. In one or more exemplary electrode assemblies, eachof at least two first electrodes of the first set of first electrodesforms a part of at least two sensor points, such as at least threesensor points.

The first set of first electrodes may comprise one, two, three, or moreelectrodes. In one or more exemplary electrode assemblies, the first setof first electrodes comprises at least three electrodes, such as atleast five electrodes.

In one or more exemplary electrode assemblies, a second electrode of thesecond set of second electrodes forms a part of a first sensor point anda third sensor point of the plurality of sensor points. In one or moreexemplary electrode assemblies, a second electrode of the second set ofsecond electrodes forms a part of at least two sensor points, such as atleast three sensor points. In one or more exemplary electrodeassemblies, each of at least two second electrodes of the second set ofsecond electrodes forms a part of at least two sensor points, such as atleast three sensor points.

The second set of second electrodes may comprise one, two, three, ormore electrodes. In one or more exemplary electrode assemblies, thesecond set of second electrodes comprises at least three secondelectrodes, such as at least five electrodes.

In one or more exemplary electrode assemblies, first electrode(s) of thefirst set of electrodes comprises three or more sensing parts, such asthree, four, five or more sensing parts. In one or more exemplaryelectrode assemblies, a first primary electrode and a first secondaryelectrode of the first set of electrodes each comprises three or moresensing parts, such as three, four, five or more sensing parts. In oneor more exemplary electrode assemblies, a first tertiary electrode ofthe first set of electrodes comprises three or more sensing parts, suchas three, four, five or more sensing parts. In one or more exemplaryelectrode assemblies, a first quaternary electrode of the first set ofelectrodes comprises three or more sensing parts, such as three, four,five or more sensing parts. In one or more exemplary electrodeassemblies, a first quinary electrode of the first set of electrodescomprises three or more sensing parts, such as three, four, five or moresensing parts.

In one or more exemplary electrode assemblies, second electrode(s) ofthe second set of electrodes comprises three or more sensing parts, suchas three, four, five or more sensing parts. In one or more exemplaryelectrode assemblies, a second primary electrode and a second secondaryelectrode of the second set of electrodes each comprises three or moresensing parts, such as three, four, five or more sensing parts. In oneor more exemplary electrode assemblies, a second tertiary electrode ofthe second set of electrodes comprises three or more sensing parts, suchas three, four, five or more sensing parts. In one or more exemplaryelectrode assemblies, a second quaternary electrode of the second set ofelectrodes comprises three or more sensing parts, such as three, four,five or more sensing parts. In one or more exemplary electrodeassemblies, a second quinary electrode of the second set of electrodescomprises three or more sensing parts, such as three, four, five or moresensing parts.

Sensing part(s) may be ring-shaped, annular-shaped, or loop-shaped.

A first set of first electrodes with N1 first electrodes E_1_1, E_1_2,E_1_N1 and a second set of second electrodes with N2 second electrodesE_2_1, E_2_2, E_2_N2 allow for an electrode assembly with N1 times N2sensor points. In one or more exemplary wound dressings, the number N1of first electrodes in the first set of first electrodes is in the rangefrom 1 to 30, such as in the range from 3 to 25, or in the range from 4to 20. The number N1 of first electrodes in the first set of firstelectrodes may be larger than 4, such as larger than 5 or even largerthan 6. In one or more exemplary wound dressings, the number N2 ofsecond electrodes in the second set of second electrodes is in the rangefrom 1 to 30, such as in the range from 3 to 25, or in the range from 4to 20. The number N2 of second electrodes in the second set of secondelectrodes may be larger than 4, such as larger than 5 or even largerthan 6.

The electrode assembly comprises a plurality of sensor points optionallydistributed along a distal surface of the absorbent core layer. In oneor more exemplary electrode assemblies, the plurality of sensor pointscomprises at least nine sensor points. The plurality of sensor pointsmay be arranged in a matrix configuration. The plurality of sensorpoints may comprise at least 20 sensor points, such as 25, 30, 36, 40,49 or more sensor points. In one or more exemplary electrode assemblies,the number of sensor points may be in the range from 20 to 50. Twoelectrodes of the electrode assembly, e.g. a first electrode of thefirst set of electrodes and a second electrode of the second set ofelectrodes (or respective sensing points thereof), may form a sensorpoint. A first electrode E_1_1 and a second electrode E_2_1 may form a(first) sensor point SP_1_1 (first electrode pair). The first electrodeE_1_1 and a second electrode E_2_2 may form a (second) sensor pointSP_1_2 (second electrode pair). The first electrode E_1_1 and a secondelectrode E_2_3 may form a (third) sensor point SP_1_3 (third electrodepair). A first electrode E_1_2 and the second electrode E_2_1 may form a(fourth) sensor point SP_2_1 (fourth electrode pair). The firstelectrode E_1_2 and the second electrode E_2_2 may form a (fifth) sensorpoint SP_2_2 (fifth electrode pair). The first electrode E_1_2 and thesecond electrode E_2_3 may form a (sixth) sensor point SP_2_3 (sixthelectrode pair).

A first electrode E_1_3 and the second electrode E_2_1 may form a(seventh) sensor point SP_3_1 (seventh electrode pair). The firstelectrode E_1_3 and the second electrode E_2_2 may form a (eighth)sensor point SP_3_2 (eighth electrode pair). The first electrode E_1_3and the second electrode E_2_3 may form a (ninth) sensor point SP_3_3(ninth electrode pair).

A distance, such as a center-to-center distance, between twoneighbouring sensor points may be in the range from 2 mm to 50 mm, suchas about 25 mm, or about 30 mm. In one or more exemplary electrodeassemblies, a distance, such as a center-to-center distance, between twoneighbouring sensor points is in the range from 3 mm to 20 mm, such asin the range from 4 mm to 15 mm, e.g. about 5 mm, 6 mm, 7 mm, 8 mm, 9mm, or 10 mm.

The electrode assembly may comprise one or more support layers includinga first support layer. The first support layer may have a plurality ofsensor point openings, e.g. for allowing exudate to pass through thefirst support layer. A sensor point opening of the first support layermay form a part of one or more sensor points of the electrode assembly.In one or more exemplary electrode assemblies, sensing part(s) of afirst electrode surrounds sensor point opening(s) of the first supportlayer.

The first set of electrodes may be printed or arranged on the firstsupport layer. In one or more exemplary electrode assemblies, the firstset of electrodes are printed on a proximal surface of the first supportlayer. The first set of electrodes may be printed on a distal surface ofthe first support layer.

The second set of electrodes may be printed or arranged on the firstsupport layer. In one or more exemplary electrode assemblies, the secondset of electrodes are printed on a proximal surface of the first supportlayer. The second set of electrodes may be printed on a distal surfaceof the first support layer. The second set of electrodes may be printedor arranged on a support layer surface different than the support layersurface on which the first set of electrodes is printed or arranged.Arranging the first set of electrodes and the second set of electrodeson different support layer surfaces allows for provision of a largernumber of sensor points using a smaller number of electrodes.

The electrode assembly may comprise a second support layer. The secondset of electrodes may be printed or arranged on the second supportlayer. In one or more exemplary electrode assemblies, the second set ofelectrodes are printed on a proximal surface of the second supportlayer. The second set of electrodes may be printed on a distal surfaceof the second support layer.

The second support layer may have a plurality of sensor point openings,e.g. for allowing exudate to pass through the second support layer. Asensor point opening of the second support layer may form a part of oneor more sensor points of the electrode assembly. In one or moreexemplary electrode assemblies, sensing part(s) of a second electrodesurrounds sensor point opening(s) of the first support layer and/orsensor point opening(s) of the second support layer.

A support layer, such as the first support layer and/or the secondsupport layer, may comprise polymeric (e.g. polyurethane, PTFE, PVDF)and/or ceramic (e.g. alumina, silica) materials. In one or moreexemplary wound dressings, the first support layer and/or the secondsupport layer is/are made of thermoplastic polyurethane (TPU). Thesupport layer material may be made of or comprise one or more ofpolyester, a thermoplastic elastomer (TPE), polyimide, polyimide,Ethylene-vinyl acetate (EVA), polyurea, and silicones. Exemplarythermoplastic elastomers of the first support layer and/or the secondsupport layer are styrenic block copolymers (TPS, TPE-s), thermoplasticpolyolefin elastomers (TPO, TPE-o), thermoplastic Vulcanizates (TPV,TPE-v), thermoplastic polyurethanes (TPU), thermoplastic copolyester(TPC, TPE-E), and thermoplastic polyamides (TPA, TPE-A).

The electrode assembly may comprise a spacing layer between the firstsupport layer and the second support layer. A spacing layer between thefirst support layer and the second support layer may reduce the risk offalse positives when detecting and/or determining moisture/liquidpatterns or distributions. The spacing layer may have a plurality ofsensor point openings, e.g. for allowing exudate to pass through thespacing layer. The spacing layer may be made of an absorbent material.The spacing layer may have a thickness in the range from 1 μm to 1 mm,such as about 10 μm or 100 μm.

The electrode assembly may have a first part and a second part.

The first part may comprise at least some of or all the connection partsof the plurality of electrodes. The first part of the electrode assemblymay extend through the top layer opening. In one or more exemplary wounddressings, at least some of the connection parts of the plurality ofelectrodes are arranged on a proximal surface of the electrode assembly.The first part of the electrode assembly may extend outside theabsorbent core layer when seen in a radial direction. Accordingly, theconnection parts of the plurality of electrodes may be arranged outsidethe absorbent core layer when seen in a radial direction. The first partmay be elongated, e.g. having a length of at least 2 cm, such as atleast 5 cm, e.g. in the range from 5 cm to 30 cm. An elongated firstpart may facilitate attachment and detachment of the monitor deviceand/or reduce the wear discomfort by allowing positioning of the monitordevice away from the wound.

The electrode assembly may comprise a reinforcement element. Thereinforcement element may form at least part of the first part of theelectrode assembly. The reinforcement element optionally comprises aplurality of conductive paths respectively connected to connection partsof the plurality of electrodes. The conductive paths of thereinforcement element may form terminals of the monitor interface. Thereinforcement element may be a flex circuit.

The second part may be arranged between the absorbent core layer and thetop layer, i.e. the second part may be arranged to overlap with theabsorbent core layer when seen in an axial direction. Thus, the secondpart of the electrode assembly may comprise the plurality of sensorpoints distributed along a distal surface of the absorbent core layer.

The electrode assembly/wound dressing may comprise one or more maskinglayers including a first masking layer isolating electrode parts of theplurality of electrodes. The first masking layer may isolate electrodeparts of first electrodes of the first set of first electrodes.

The first masking layer may be printed on the first support layer andoptionally cover one or more parts of electrodes printed or arranged onthe first support layer. In one or more exemplary electrode assemblies,the first masking layer is printed on the proximal side of the firstsupport layer and covering one or more parts of first electrodes and/orsecond electrodes. In one or more exemplary electrode assemblies, thefirst masking layer is printed on the distal side of the first supportlayer and covering one or more parts of first electrodes and/or secondelectrodes.

The first masking layer may be printed on the second support layer andoptionally cover one or more parts of electrodes printed or arranged onthe second support layer. In one or more exemplary electrode assemblies,the first masking layer is printed on the proximal side of the secondsupport layer and covering one or more parts of second electrodes. Inone or more exemplary electrode assemblies, the first masking layer isprinted on the distal side of the second support layer and covering oneor more parts of second electrodes.

The first masking layer may be divided in a plurality of first maskinglayer parts. The first masking layer may be arranged between theabsorbent core layer and at least parts of the first electrodes toelectrically isolate the parts of the first electrodes from theabsorbent core layer. The first masking layer may be arranged betweenthe absorbent core layer and at least parts of the second electrodes toelectrically isolate the parts of the second electrodes from theabsorbent core layer.

The first masking layer may comprise one or more, such as a pluralityof, sensor point openings. A sensor point opening of the first maskinglayer optionally overlaps at least one electrode of the electrodeassembly when seen in the axial direction, e.g. to form a sensor point.For example, a sensor point opening of the first masking layer mayoverlap a (sensing) part of a first electrode of the first set ofelectrodes and a (sensing) part of a second electrode of the second setof electrodes.

The electrode assembly may comprise a second masking layer isolatingelectrode parts of the plurality of electrodes.

The second masking layer may be printed on the first support layer andoptionally cover one or more parts of electrodes printed or arranged onthe first support layer. In one or more exemplary electrode assemblies,the second masking layer is printed on the distal side of the firstsupport layer and covering one or more parts of second electrodes.

The second masking layer may be printed on the second support layer andoptionally cover one or more parts of electrodes printed or arranged onthe second support layer. In one or more exemplary electrode assemblies,the second masking layer is printed or arranged on the proximal side ofthe second support layer and covering one or more parts of secondelectrodes. In one or more exemplary electrode assemblies, the secondmasking layer is printed or arranged on the distal side of the secondsupport layer and covering one or more parts of second electrodes.

The second masking layer may be divided in a plurality of second maskinglayer parts. The second masking layer may be arranged between theabsorbent core layer and at least parts of the second electrodes toelectrically isolate the parts of the second electrodes from theabsorbent core layer. The second masking layer may be arranged betweenthe first support layer and at least parts of the second electrodes toelectrically isolate the parts of the second electrodes from the firstsupport layer. The second masking layer may be arranged between thespacing layer and at least parts of the second electrodes toelectrically isolate the parts of the second electrodes from the spacinglayer.

The second masking layer may comprise one or more, such as a pluralityof, sensor point openings. A sensor point opening of the second maskinglayer optionally overlaps at least one electrode of the electrodeassembly when seen in the axial direction, e.g. to form a sensor point.For example, a sensor point opening of the second masking layer mayoverlap a (sensing) part of a first electrode of the first set ofelectrodes and/or a (sensing) part of a second electrode of the secondset of electrodes.

A masking layer, e.g. the first masking layer and/or the second maskinglayer, may comprise one or more, such as a plurality of, terminalopenings. A terminal opening may overlap with one or more connectionparts of electrodes. In one or more exemplary wound dressings, eachterminal opening overlaps with a single connection part of an electrode.A masking layer, e.g. the first masking layer and/or the second maskinglayer, may comprise polymeric (e.g. polyurethane, PTFE, PVDF) and/orceramic (e.g. alumina, silica) materials. In one or more exemplary wounddressings, the first masking layer and/or the second masking layeris/are made of or comprises thermoplastic polyurethane (TPU). In one ormore exemplary wound dressings, the first masking layer and/or thesecond masking layer is made of or comprises polyester. The maskingelement material may be made of or comprise one or more of polyester, athermoplastic elastomer (TPE), polyamide, polyimide, Ethylene-vinylacetate (EVA), polyurea, and silicones.

Exemplary thermoplastic elastomers of the first masking layer and/or thesecond masking layer are styrenic block copolymers (TPS, TPE-s),thermoplastic polyolefin elastomers (TPO, TPE-o), thermoplasticVulcanizates (TPV, TPE-v), thermoplastic polyurethanes (TPU),thermoplastic copolyester (TPC, TPE-E), and thermoplastic polyamides(TPA, TPE-A).

The wound dressing comprises a monitor interface. The monitor interfacemay be configured for electrically and/or mechanically connecting thewound dressing (electrode assembly) to the monitor device. The monitorinterface may be configured for wirelessly connecting the wound dressingto the monitor device. Thus, the monitor interface of the wound dressingis configured to electrically and/or mechanically couple the wounddressing and the monitor device.

The monitor interface of the wound dressing may comprise, e.g. as partof a first connector of the monitor interface, a coupling part forforming or configured for forming a mechanical connection, such as areleasable coupling between the monitor device and the wound dressing.The coupling part may be configured to engage with a coupling part ofthe monitor device for releasably coupling the monitor device to thewound dressing.

The coupling part may be attached, such as glued, welded, press-fitted,or soldered, to the electrode assembly. In one or more exemplary wounddressings, the coupling part extends through the top layer opening, i.e.a part of the coupling part may extend on the proximal side of the toplayer and a part of the coupling part may extend on the distal side ofthe top layer. The coupling part may be attached such as glued, welded,press-fitted, or soldered, to the top layer.

In one or more exemplary wound dressings, the first part of theelectrode assembly extends into the coupling part, i.e. the couplingpart may accommodate at least a part of the first part of the electrodeassembly.

The monitor interface of the wound dressing may comprise, e.g. as partof a first connector of the monitor interface, a plurality of terminals,such as two, three, four, five, six, seven, eight or more terminals, forforming or configured to form electrical connections with respectiveterminals of the monitor device. The monitor interface may comprise aground terminal element forming a ground terminal. The monitor interfacemay comprise a first terminal element forming a first terminal, a secondterminal element forming a second terminal and optionally a thirdterminal element forming a third terminal. The monitor interface maycomprise a fourth terminal element forming a fourth terminal and/or afifth terminal element forming a fifth terminal. The monitor interfaceoptionally comprises a sixth terminal element forming a sixth terminal.The terminal elements of the monitor interface may contact respectiveelectrodes (connection parts) of the wound dressing/electrode assembly.In one or more exemplary wound dressings, a first intermediate elementmay be arranged between the terminal elements and the first adhesivelayer. The first intermediate element may cover or overlap terminalelement(s) of the wound dressing when seen in the axial direction. Thus,the first adhesive layer may be protected or experience more evenlydistributed mechanical stress from the terminal elements of the wounddressing, in turn reducing the risk of terminal elements penetrating orotherwise damaging the first adhesive layer. The first intermediateelement may protect or mechanically and/or electrically shield the firstadhesive layer from the terminal elements of the wound dressing.

A terminal element, such as the ground terminal element, the firstterminal element, the second terminal element, the third terminalelement, the fourth terminal element, the fifth terminal element and/orthe sixth terminal element, may comprise a distal end and a proximalend. A terminal element, such as the ground terminal element, the firstterminal element, the second terminal element, the third terminalelement, the fourth terminal element, the fifth terminal element and/orthe sixth terminal element, may comprise a distal part (with a distalend), a centre part, and/or a proximal part (with a proximal end). Thecentre part may be between the distal part and the proximal part. Theproximal end/proximal part of a terminal element may contact aconnection part of an electrode. A terminal element, such as the groundterminal element, the first terminal element, the second terminalelement, the third terminal element, the fourth terminal element, thefifth terminal element and/or the sixth terminal element, may be goldplated copper.

In one or more exemplary wound dressings, connection parts of electrodesof the electrode assembly form respective terminals of the monitorinterface.

The wound dressing may comprise a flexible element, the flexible elementbeing bendable and/or twistable between a first flexible element end anda second flexible element end. The coupling part of the monitorinterface may be positioned at the first flexible element end. Forexample, the monitor interface may comprise the flexible element. Afirst part of the top layer and/or a first part of the electrodeassembly may at least partly form the first flexible element. Thecoupling part is configured for forming a mechanical connection, such asa releasable coupling, between the monitor device and the wounddressing. The flexible element may have a length larger than 1 cm, suchas larger than 2 cm, larger than 3 or even larger than 5 cm. Theflexible element may at least partly extend on the distal side of thetop layer.

Providing the coupling part of the wound dressing at an end of aflexible element may provide the advantage that the monitor device,after being coupled to the wound dressing, may be positioned in anadvantageous position, such as in a designated position. Thus, themonitor device may be more freely positioned after being coupled to thewound dressing. Furthermore, the flexible element may facilitate foreasier coupling the monitor device and the wound dressing since thecoupling part may be turned, twisted and/or repositioned upon couplingof the monitor device to the wound dressing. Providing for an easiercoupling of the monitor device to the wound dressing, may be ofparticular importance for a user, since the wound dressing may besituated on the body in a position complicating coupling of the monitordevice. For example, the wound dressing may be partly hidden, such thatthe user needs to use a mirror in order to see what he/she is doing incoupling the monitor device to the wound dressing. Also, the wounddressing may be positioned to restrict the possibility for the user touse both hands. It is therefore a further advantage of the presentdisclosure, that it may facilitate the coupling of the monitor device tothe wound dressing using both hands.

The coupling part of the monitor interface is optionally configured toengage with the monitor device by a linear motion in an engagementdirection of the monitor device relative to the wound dressing. Themonitor device coupling part may be configured to engage with the wounddressing, such as with the coupling part of the wound dressing, by alinear motion in the engagement direction of the monitor device relativeto the wound dressing. For example, the monitor device, such as themonitor device coupling part, and the wound dressing, such as thecoupling part of the wound dressing, may be transferred from beingdecoupled to being coupled by a linear motion, such as a single linearmotion, in the engagement direction of the monitor device relative tothe wound dressing.

The engagement direction may be substantially parallel, e.g. within ±10degrees, to a longitudinal direction of the flexible element at thefirst flexible element end.

The coupling part may be configured to disengage with the monitor deviceby a linear motion in a disengagement direction of the monitor devicerelative to the wound dressing. The monitor device coupling part may beconfigured to disengage with the wound dressing, such as with thecoupling part of the wound dressing, by a linear motion in thedisengagement direction of the monitor device relative to the wounddressing. For example, the monitor device, such as the monitor devicecoupling part, and the wound dressing, such as the coupling part of thewound dressing, may be transferred from being coupled to being decoupledby a linear motion, such as a single linear motion, in the disengagementdirection of the monitor device relative to the wound dressing. Thedisengagement direction may be opposite the engagement direction.Alternatively, the disengagement direction may be perpendicular to theengagement direction.

The first adhesive layer may be substantially planar, e.g. prior tobeing applied to a user's skin. The first adhesive layer may extend in awound dressing plane. The flexible element may have a longitudinaldirection, such as from the second flexible element end to the firstflexible element bend. The longitudinal direction of the flexibleelement may be dependent on position between the first flexible elementend and the second flexible element end. The engagement direction and/orthe disengagement direction may be substantially parallel to thelongitudinal direction of the flexible element at the first flexibleelement end.

In one or more exemplary wound dressings, the wound dressing comprises alocking mechanism configured to lock the monitor device in a coupledposition with the wound dressing. Alternatively, or additionally, themonitor device may comprise a locking mechanism. The lockingmechanism(s) may be configured to lock the monitor device in a coupledposition with the wound dressing. For example, the locking mechanism(s)may provide that the monitor device is maintained in the coupledposition with the wound dressing. The locking mechanism(s) may beconfigured to automatically lock the monitor device in the coupledposition with the wound dressing. The locking mechanism may be biased,e.g. spring-biased, towards locking of the locking mechanism. Forexample, the locking mechanism(s) may be biased, e.g. spring biased,towards locking of the locking mechanism(s). For example, the lockingmechanism may comprise biasing means, e.g. a spring, that biases thelocking mechanism towards a locked position. The locking mechanism(s)may be configured to unlock the monitor device from the coupled positionwith the wound dressing upon user interaction. Alternatively, oradditionally, the locking mechanism(s) may be configured to lock themonitor device in the coupled position with the wound dressing upon userinteraction.

The locking mechanism may comprise a locking element optionallyconfigured to unlock and/or lock the locking mechanism upon userinteraction with the locking element. The locking element may also bedenoted an unlocking element. The locking element(s) may form part ofthe locking mechanism(s). The locking element(s) may be configured tounlock and/or lock the locking mechanism(s), e.g. upon user interactionwith the locking element(s). For example, the locking element(s) maycomprise button(s) for user interaction. For example, the lockingelement(s) may be engaged to lock the locking mechanism and/or thelocking element(s) may be engaged to unlock the locking mechanism. Userinteraction with the locking element(s) may comprise deflection of oneor more buttons or sliding of a slider etc.

The locking element may comprise a first button being deflectable in afirst direction. The first direction may be substantially perpendicularto the engagement direction, e.g. form an angle in the range from 80 to100 degrees. The locking element optionally comprises a first button anda second button, the first button being deflectable in a first directionand the second button being deflectable in a second direction. The firstdirection may be substantially opposite the second direction. In one ormore exemplary wound dressings, the first direction and the seconddirection are substantially perpendicular to the engagement direction,e.g. form an angle in the range from 80 to 100 degrees.

The locking element of the wound dressing may comprise a slider beingslidable in a first slider direction, and wherein the slider is springloaded and biased towards a second slider direction. The first sliderdirection is optionally opposite the second slider direction. In one ormore exemplary wound dressings, the first slider direction and thesecond slider direction are substantially parallel to the engagementdirection.

The wound dressing, such as the monitor interface, such as the couplingpart, may comprise a locking section. Alternatively, or additionally,the monitor device may comprise a locking section. The lockingsection(s) may be configured to cooperate with a respective lockingmechanism. For example a locking section of the wound dressing may beconfigured to cooperate with a locking mechanism of the monitor device,and/or a locking section of the monitor device may be configured tocooperate with a locking mechanism of the wound dressing.

The locking section(s) may comprise a hole extending through a couplingpart, such as the coupling part of the wound dressing and/or the monitordevice coupling part of the monitor device. Alternatively, oradditionally, the locking section(s) may comprise a protrusionprotruding from a surface of the coupling part and/or monitor devicecoupling part. Alternatively, or additionally, the locking section maycomprise an indent in an edge of the coupling part and/or monitor devicecoupling part. Alternatively, or additionally, the locking section maycomprise a recess in a surface of the coupling part and/or monitordevice coupling part.

The wound dressing may comprise a first attachment element and a secondattachment element. The first attachment and the second attachmentelement may be attached to each other. The first attachment element isoptionally positioned at the first flexible element end and the secondattachment element optionally extends on the distal side of the toplayer. The first attachment element may be configured to attach to thesecond attachment element. The first attachment element may in the formof a clamp configured to clamp to the second attachment element. Thefirst attachment element and the second attachment element may form ahook-and-loop coupling. The hook-and-loop coupling may be Velcro. Thefirst attachment element and the second attachment element may form amagnetic coupling. The first attachment element may be a button element.The second attachment element may be a button element.

The coupling part(s), such as the monitor device coupling part and/orthe coupling part of the wound dressing, may form a USB type plug orport. For example, the coupling part(s) may conform with a USB standard.

The monitor device comprises a processor and one or more interfaces,such as a first interface and/or a second interface. The monitor devicemay comprise a memory for storing wound data and/or parameter data basedon the wound data.

The first interface is connected to the processor and the memory. Thefirst interface is configured for collecting wound data from the wounddressing coupled to the first interface. The wound data, also denotedWD, comprises wound data from sensor points of the wound dressing, e.g.first wound data WD_1 from a first sensor point, e.g. a first electrodepair, of the wound dressing, second wound data WD_2 from a second sensorpoint, e.g. a second electrode pair, of the wound dressing, andoptionally third wound data WD_3 from a third sensor point, e.g. a thirdelectrode pair, of the wound dressing. In one or more exemplary monitordevices, the wound data comprises wound data for each sensor point ofthe wound dressing. For example, for a wound dressing with N sensorpoints, the wound data WD may comprise WD_1, WD_2, WD_N. The number N ofsensor points of the wound dressing may be at least 9, such as at least20 or even larger than 50.

The processor is configured to apply a processing scheme. To apply aprocessing scheme comprises to obtain parameter data based on the wounddata, e.g. the first wound data WD_1, the second wound data WD_2, andthe third wound data WD_3; and to determine an operating state of thewound dressing based on the parameter data. The parameter data maycomprise one or more of first parameter data, also denoted P_1, based onthe first wound data WD_1, second parameter data, also denoted P_2,based on the second wound data WD_2, and third parameter data, alsodenoted P_3, based on the third wound data WD_3.

The operating state of the wound dressing is optionally indicative of adegree of wetting of the absorbent core layer of the wound dressing. Theoperating state is optionally indicative of a degree of wetting of thedistal surface of the absorbent core layer. The operating state may beindicative of a wetting pattern or wetting distribution on the distalsurface or distal side of the absorbent core layer.

The monitor device is optionally configured to, in accordance with adetermination that the operating state is a first operating state,transmit a first monitor signal comprising monitor data indicative ofthe first operating state of the wound dressing via the secondinterface. The first operating state of the wound dressing maycorrespond to a situation wherein the absorbent core layer is wetted toa first degree on the distal surface of the absorbent core layer and/orwherein a first wetting pattern is detected on the distal surface of theabsorbent core layer.

The monitor device is optionally configured to, in accordance with adetermination that the operating state is a second operating state,transmit a second monitor signal comprising monitor data indicative ofthe second operating state of the wound dressing via the secondinterface. The second operating state of the wound dressing maycorrespond to a situation wherein the absorbent core layer is wetted toa second degree (different from the first degree) on the distal surfaceof the absorbent core layer and/or wherein a second wetting pattern isdetected on the distal surface of the absorbent core layer.

In one or more exemplary monitor devices, to determine an operatingstate of the wound dressing is based on a first criteria set based onfirst parameter data and/or second parameter data of the parameter data,wherein the operating state is determined to be the first operatingstate if the first criteria set is satisfied. The first criteria setoptionally comprises a first primary criterion based on the firstparameter data, and a first secondary criterion based on the secondparameter data.

In one or more exemplary monitor devices, to determine an operatingstate of the wound dressing is based on a first threshold set comprisingone or more first threshold values.

In one or more exemplary monitor devices, to determine an operatingstate of the wound dressing is based on a second criteria set based onfirst parameter data and second parameter data of the parameter data,wherein the operating state is determined to be the second operatingstate if the second criteria set is satisfied. The second criteria setoptionally comprises a second primary criterion based on the firstparameter data, and a second secondary criterion based on the secondparameter data. Applying first and second criteria set based on firstparameter data and second parameter data allows for a distinctionbetween different degrees and/or patterns of wetting.

In one or more exemplary monitor devices, to determine an operatingstate of the wound dressing is based on a second threshold setcomprising one or more second threshold values.

In one or more exemplary monitor devices, to determine an operatingstate of the wound dressing is based on a default criteria set based onthe parameter data, wherein the operating state is determined to be thedefault operating state if the default criteria set is satisfied, andoptionally in accordance with a determination that the operating stateis the default operating state, transmit a default monitor signalcomprising monitor data indicative of the default operating state of thewound dressing. The default operating state may correspond to no wettingor a low degree of wetting of the (distal surface or side of) absorbentcore layer.

In one or more exemplary monitor devices, to determine an operatingstate of the wound dressing is based on a third criteria set based onthird parameter data of the parameter data, wherein the operating stateis determined to be the third operating state if the third criteria setis satisfied. The third operating state of the wound dressing maycorrespond to a situation wherein the absorbent core layer is wetted toa third degree on the distal surface of the absorbent core layer and/orwherein a third wetting pattern is detected on the distal surface of theabsorbent core layer.

The monitor device is optionally configured to, in accordance with adetermination that the operating state is the third operating state,transmit a third monitor signal comprising monitor data indicative ofthe third operating state of the wound dressing.

The parameter data may be indicative of resistance between the twoelectrodes of an electrode pair forming a sensor point. For example, thefirst parameter data, the second parameter data, and the third parameterdata, may be indicative of resistance between first electrode pair ofthe first sensor point, second electrode pair of the second sensorpoint, and third electrode pair of the third sensor point, respectively.Wetting of the distal surface of the absorbent core layer with exudate,i.e. exudate from the wound being absorbed by the absorbent core layer,is detected by a reduced resistance between the two electrodes of thesensor point(s). The sensor points are arranged or distributed along thedistal surface of the absorbent core layer allowing the monitor deviceto detect and/or derive a degree of wetting and/or a wetting pattern orwetting distribution on the distal surface of the of the absorbent corelayer.

In one or more exemplary monitor devices, the parameter data areindicative of a rate of change in resistance between the two electrodesof an electrode pair forming a sensor point. The first parameter data,the second parameter data, and the third parameter data may beindicative of a rate of change in resistance between first electrodepair of the first sensor point, second electrode pair of the secondsensor point, and third electrode pair of the third sensor point,respectively.

In one or more exemplary monitor devices, the wound data comprisesfourth wound data from a fourth sensor point of the wound dressing, andwherein to apply a processing scheme comprises to obtain fourthparameter data based on the fourth wound data, and determine anoperating state of the wound dressing based on the fourth parameterdata.

The monitor device is optionally configured to, in accordance with adetermination that the operating state is a fourth operating state,transmit a fourth monitor signal comprising monitor data indicative ofthe fourth operating state of the wound dressing. The fourth operatingstate of the wound dressing may correspond to a situation wherein theabsorbent core layer is wetted to a fourth degree on the distal surfaceof the absorbent core layer and/or wherein a fourth wetting pattern isdetected on the distal surface of the absorbent core layer.

In one or more exemplary monitor devices, to obtain parameter datacomprises to obtain common parameter data of the parameter data based ona plurality of the first wound data, the second wound data, and thethird wound data, and wherein to determine the operating state of thewound dressing is based on the common parameter data.

In one or more exemplary monitor devices, to determine an operatingstate comprises to determine a degree of wetting of the absorbent corelayer, such as a degree of wetting of the distal side or surface of theabsorbent core material. To determine a degree of wetting of theabsorbent core material may comprising to determine if the degree ofwetting satisfies first wetting criterion and/or if the degree ofwetting satisfies second wetting criterion.

The monitor device is optionally configured to, in accordance with thedegree of wetting satisfying first wetting criterion, setting theoperating state to be the first operating state and optionally includethe degree of wetting in the monitor data.

The monitor device is optionally configured to, in accordance with thedegree of wetting satisfying a second wetting criterion, setting theoperating state to be the second operating state and optionally includethe degree of wetting in the monitor data.

In one or more exemplary monitor devices, to determine an operatingstate comprises to determine a wetting pattern of the absorbent corelayer, such as a wetting pattern on the distal side or surface of theabsorbent core material, and optionally to determine a pattern type ofthe wetting pattern from a plurality of pattern types. To determine apattern type of the wetting pattern may comprise to determine if thewetting pattern satisfies first pattern type criterion, wherein thepattern type is determined as being a first pattern type if the firstpattern type criterion is satisfied. To determine a pattern type of thewetting pattern may comprise to determine if the wetting patternsatisfies second pattern type criterion, wherein the pattern type isdetermined as being a second pattern type if the second pattern typecriterion is satisfied.

The monitor device may be configured to, in accordance with the patterntype being a first pattern type, setting the operating state to be thefirst operating state and optionally including a pattern representationof the wetting pattern in the monitor data. The pattern representationmay comprise a pattern type identifier and/or pattern data indicative ofparameter data.

The monitor device may be configured to, in accordance with the patterntype being a second pattern type, setting the operating state to be thesecond operating state and optionally including a pattern representationof the wetting pattern in the monitor data. The pattern representationmay comprise a pattern type identifier and/or pattern data indicative ofparameter data.

The monitor device comprises a second interface connected to theprocessor. The second interface may comprise a loudspeaker connected tothe processor, and wherein the processor is configured to transmit amonitor signal via the loudspeaker. In one or more exemplary monitordevices, the second interface comprises an antenna and a wirelesstransceiver, and wherein the processor is configured to transmit amonitor signal as a wireless monitor signal via the antenna and thewireless transceiver.

A wound dressing system is disclosed, the wound dressing systemcomprising a wound dressing and a monitor device, the wound dressingcomprising an absorbent core layer, wherein the monitor device is amonitor device as described herein.

To obtain first parameter data based on the first wound data maycomprise determining one or more first parameters based on the firstwound data. To obtain second parameter data based on the second wounddata may comprise determining one or more second parameters based on thesecond wound data. To obtain third parameter data based on the thirdwound data may comprise determining one or more third parameters basedon the third wound data. In one or more exemplary monitor devices,determination of an operating state may be based on one or more firstparameters, such as first primary parameter and/or first secondaryparameter of first parameter data. In one or more exemplary monitordevices, determination of an operating state may be based on one or moresecond parameters, such as second primary parameter and/or secondsecondary parameter of the second parameter data. In one or moreexemplary monitor devices, determination of an operating state may bebased on one or more third parameters, such as third primary parameterand/or third secondary parameter of the third parameter data.

In one or more exemplary monitor devices, determination of an operatingstate may be based on one or more fourth parameters, such as fourthprimary parameter and/or fourth secondary parameter of the fourthparameter data.

Parameter data, P_1, P_2, . . . , P_N, may comprise respectiveparameters p_1_1, p_2_1, . . . , p_N_1 indicative of resistance betweenthe respective two electrodes forming a sensor point of the wounddressing. Parameter data, P_1, P_2, . . . , P_N, may comprise respectiveparameters p_1_2, p_2_2, . . . , p_N_2 each indicative of a rate ofchange in resistance between the respective two electrodes forming asensor point of the wound dressing. Accordingly, p_1_1 of P_1 may be theresistance measured between the first electrode E_1_1 and the secondelectrode E_2_1 forming the first sensor point SP_1_1, p_2_1 of P_2 maybe the resistance measured between first electrode E_1_1 and the secondelectrode E_2_2 forming the second sensor point SP_1_2.

In one or more exemplary monitor devices and/or methods, to determine anoperating state of the wound dressing is based on a first criteria setbased on the first parameter data P_1 (p_1_1) and/or one or more otherparameter data P_2 (p_2_1), P_3 (p_3_1), . . . , P_N (p_N_1), whereinthe operating state is determined to be the first operating state if thefirst criteria set is satisfied. The first criteria set may comprise oneor more first criteria based on one or more of P_1, P_2, . . . , P_N.The first criteria set may comprise a first primary criterion based onP_1 (p_1_1). The first criteria set may comprise a first secondarycriterion based on P_2 (p_2_1). The first criteria set may comprise afirst tertiary criterion based on P_3 (p_3_1). The first criteria setmay comprise N first criteria respectively based on P_1, P_2, . . . ,P_N.

In one or more exemplary monitor devices and/or methods, to determine anoperating state of the wound dressing is based on a second criteria setbased on the second parameter data P_2 (p_2_1) and/or one or more otherparameter data P_1 (p_1_1), P_3 (p_3_1), . . . , P_N (p_N_1), whereinthe operating state is determined to be the second operating state ifthe second criteria set is satisfied. The second criteria set maycomprise one or more second criteria based on one or more of P_1, P_2, .. . , P_N. The second criteria set may comprise a second primarycriterion based on P_1 (p_1_1). The second criteria set may comprise asecond secondary criterion based on P_2 (p_2_1). The second criteria setmay comprise a second tertiary criterion based on P_3 (p_3_1). Thesecond criteria set may comprise N second criteria respectively based onP_1, P_2, . . . , P_N.

In one or more exemplary monitor devices and/or methods, to determine anoperating state of the wound dressing may comprise to determine thenumber of parameters p_1_1, p_2_1, . . . , p_N_1 having resistances lessthan a first threshold as a first common parameter of common parameterdata. The operating state of the wound dressing may be based on thenumber of parameters p_1_1, p_2_1, . . . , p_N_1 having resistances lessthan a first threshold. The operating state of the wound dressing may bedetermined as the first operating state if the first common parameterbeing the number of parameters p_1_1, p_2_1, . . . , p_N_1 havingresistances less than a first threshold is in a first range, e.g. from0.25N to 0.5N. The first operating state may be indicative of alow-wetted absorbent core layer, i.e. a high degree of remainingabsorbent capacity of the wound dressing/absorbent core layer. Theoperating state of the wound dressing may be determined as the secondoperating state if the first common parameter being the number ofparameters p_1_1, p_2_1, . . . , p_N_1 having resistances less than afirst threshold is in a second range, e.g. from 0.5N to 0.75N. Thesecond operating state may be indicative of a medium-wetted absorbentcore layer, i.e. a medium degree of remaining absorbent capacity of thewound dressing/absorbent core layer.

The operating state of the wound dressing may be determined as a defaultoperating state if the first common parameter being the number ofparameters p_1_1, p_2_1, . . . , p_N_1 having resistances less than afirst threshold is less than a default threshold. The default thresholdmay be a fixed value or based on the number N of sensor points. Thedefault threshold may be 0.1 N or 0.25 N. The processor is optionallyconfigured to, in accordance with a determination that the operatingstate is the default operating state, transmit a default monitor signalcomprising monitor data indicative of the default operating state of thewound dressing. The default operating state may be indicative of asubstantially non-wetted absorbent core layer, i.e. a very high degreeof remaining absorbent capacity of the wound dressing/absorbent corelayer.

In one or more exemplary monitor devices and/or methods, to determine anoperating state of the wound dressing is based on a default criteria setbased on parameter data P_1, P_2, . . . , P_N, wherein the operatingstate is determined to be the default operating state if the defaultcriteria set is satisfied. The monitor device may be configured to, inaccordance with a determination that the operating state is the defaultoperating state, transmit a default monitor signal comprising monitordata indicative of the default operating state of the wound dressing.

In one or more exemplary monitor devices and/or methods, to determine anoperating state of the wound dressing is based on a third criteria setbased on parameter data P_1, P_2, . . . , P_N, wherein the operatingstate is determined to be the third operating state if the thirdcriteria set is satisfied. The operating state of the wound dressing maybe determined as the third operating state if the first common parameterbeing the number of parameters p_1_1, p_2_1, . . . , p_N_1 havingresistances less than a first threshold is in a third range, e.g. from0.75N to 0.9N.

The processor is optionally configured to, in accordance with adetermination that the operating state is the third operating state,transmit a third monitor signal comprising monitor data indicative ofthe third operating state of the wound dressing. In one or moreexemplary monitor devices, the third operating state of the wounddressing corresponds to a situation wherein the absorbent core layer iswetted to a third degree on the distal surface. The third degree may beindicative of low degree of remaining absorbent capacity of the wounddressing/absorbent core layer.

In one or more exemplary monitor devices and/or methods, to determine anoperating state of the wound dressing is based on a fourth criteria setbased on parameter data P_1, P_2, . . . , P_N, wherein the operatingstate is determined to be the fourth operating state if the fourthcriteria set is satisfied. The operating state of the wound dressing maybe determined as the fourth operating state if the first commonparameter being the number of parameters p_1_1, p_2_1, . . . , p_N_1having resistances less than a first threshold is in a fourth range,e.g. from 0.9N to N.

The processor is optionally configured to, in accordance with adetermination that the operating state is the fourth operating state,transmit a fourth monitor signal comprising monitor data indicative ofthe fourth operating state of the wound dressing. In one or moreexemplary monitor devices, the fourth operating state of the wounddressing corresponds to a situation wherein the absorbent core layer iswetted to a fourth degree on the distal surface. The fourth degree maybe indicative of very low or no degree of remaining absorbent capacityof the wound dressing/absorbent core layer.

The monitor device comprises a monitor device housing optionally made ofa plastic material. The monitor device housing may be an elongatehousing having a first end and a second end. The monitor device housingmay have a length or maximum extension along a longitudinal axis in therange from 1 cm to 15 cm. The monitor device housing may have a width ormaximum extension perpendicular to the longitudinal axis in the rangefrom 0.5 cm to 3 cm. The monitor device housing may be curve-shaped.

The monitor device comprises a first interface. The first interface maybe configured as a wound dressing interface for electrically and/ormechanically connecting the monitor device to the wound dressing. Thus,the wound dressing interface is configured to electrically and/ormechanically couple the monitor device and the wound dressing. The firstinterface may be configured as an accessory device interface forelectrically and/or mechanically connecting the monitor device to anaccessory device. The first interface may be configured for coupling toa docking station of the wound dressing system, e.g. for charging themonitor device and/or for data transfer between the monitor device andthe docking station.

The first interface of the monitor device may comprise a plurality ofterminals, such as two, three, four, five, six, seven or more terminals,for forming electrical connections with respective terminals and/orelectrodes of the wound dressing. One or more terminals of the firstinterface may be configured for forming electrical connections with anaccessory device, e.g. with respective terminals of a docking station.The first interface may comprise a ground terminal. The first interfacemay comprise a first terminal, a second terminal and optionally a thirdterminal. The first interface may comprise a fourth terminal and/or afifth terminal. The first interface optionally comprises a sixthterminal. In one or more exemplary monitor devices, the first interfacehas M terminals, wherein M is an integer in the range from 4 to 16.

The first interface of the monitor device may comprise a coupling partfor forming a mechanical connection, such as a releasable couplingbetween the monitor device and the wound dressing. The coupling part andthe terminals of the first interface form (at least part of) a firstconnector of the monitor device.

The monitor device comprises a power unit for powering the monitordevice. The power unit may comprise a battery. The power unit maycomprise charging circuitry connected to the battery and terminals ofthe first interface for charging the battery via the first interface,e.g. the first connector. The first interface may comprise separatecharging terminal(s) for charging the battery.

The monitor device may comprise a sensor unit with one or more sensors.The sensor unit is connected to the processor for feeding sensor data tothe processor. The sensor unit may comprise an accelerometer for sensingacceleration and provision of acceleration data to the processor. Thesensor unit may comprise a temperature sensor for provision oftemperature data to the processor.

The monitor device comprises a second interface connected to theprocessor. The second interface may be configured as an accessoryinterface for connecting, e.g. wirelessly connecting, the monitor deviceto one or more accessory devices and transmitting monitor data to theaccessory device. The second interface may comprise an antenna and awireless transceiver, e.g. configured for wireless communication atfrequencies in the range from 2.4 to 2.5 GHz. The wireless transceivermay be a Bluetooth transceiver, i.e. the wireless transceiver may beconfigured for wireless communication according to Bluetooth protocol,e.g. Bluetooth Low Energy, Bluetooth 4.0, Bluetooth 5. The secondinterface optionally comprises a loudspeaker and/or a haptic feedbackelement for provision of an audio signal and/or haptic feedback to theuser, respectively.

The wound dressing system may comprise a docking station forming anaccessory device of the wound dressing system. The docking station maybe configured to electrically and/or mechanically couple the monitordevice to the docking station.

The docking station may comprise a docking monitor interface. Thedocking monitor interface may be configured for electrically and/ormechanically connecting the monitor device to the docking station. Thedocking monitor interface may be configured for wirelessly connectingthe monitor device to the docking station. The docking monitor interfaceof the docking station may be configured to electrically and/ormechanically couple the docking station and the monitor device.

The docking monitor interface of the docking station may comprise, e.g.as part of a first connector of the docking monitor interface, acoupling part for forming a mechanical connection, such as a releasablecoupling between the monitor device and the docking station. Thecoupling part may be configured to engage with a coupling part of themonitor device for releasably coupling the monitor device to the dockingstation.

The docking monitor interface of the docking station may comprise, e.g.as part of a first connector of the docking monitor interface, aplurality of terminals, such as two, three, four, five, six, seven ormore terminals, for forming electrical connections with respectiveterminals of the monitor device. The docking monitor interface maycomprise a ground terminal. The docking monitor interface may comprise afirst terminal and/or a second terminal. The docking station maycomprise a third terminal. The docking monitor interface may comprise afourth terminal and/or a fifth terminal. The docking monitor interfaceoptionally comprises a sixth terminal.

Also disclosed is a monitor device, such as a monitor device asdescribed above, such as a monitor device for connecting to a wounddressing, such as the wound dressing as described herein. The monitordevice may comprise: a monitor device housing; electronic circuitry; anda wound dressing interface configured for connecting the monitor deviceto the wound dressing. The wound dressing interface of the monitordevice optionally comprises a monitor device coupling part configuredfor coupling between the monitor device and the wound dressing,

In one or more exemplary monitor devices, the monitor device comprisesan attachment element configured to attach to the wound dressing. Theattachment element of the monitor device may be in the form of a clampconfigured to clamp to an attachment element of the wound dressing. Theattachment element may be in the form of a slit configured to receive anattachment element of the wound dressing. The attachment element may bein the form of a hook element or a loop element configured to engage ina hook and loop coupling, such as Velcro, with the wound dressing. Theattachment element may be in the form of a magnetic material configuredto magnetically attach to an attachment element of the wound dressing.

The monitor device coupling part is optionally configured to engage withthe wound dressing by a linear motion in an engagement direction of themonitor device relative to the wound dressing.

The monitor device may comprise a locking mechanism configured to lockthe monitor device in a coupled position with the wound dressing. Thelocking mechanism of the monitor device may be biased towards locking ofthe locking mechanism. In one or more exemplary monitor devices, thelocking mechanism comprises a locking element configured to unlock orlock the locking mechanism upon user interaction with the lockingelement. The locking element may comprise a first button beingdeflectable in a first direction, wherein the first direction issubstantially perpendicular to the engagement direction. In one or moreexemplary monitor devices, the locking element comprises a first buttonand a second button, the first button being deflectable in a firstdirection and the second button being deflectable in a second direction,wherein the first direction is substantially opposite the seconddirection. The first direction and the second direction may besubstantially perpendicular to the engagement direction. The lockingelement of the monitor device optionally comprises a slider beingslidable in a first slider direction. The slider is optionally springloaded and biased towards a second slider direction. The first sliderdirection may be opposite the second slider direction. The first sliderdirection and the second slider direction may be substantially parallelto the engagement direction.

The monitor device, such as the monitor device housing, may have a firstsurface and a second surface. The first surface may be opposite thesecond surface. The first surface and/or the second surface may besubstantially flat. The monitor device may comprise a rim surfacebetween the first surface and the second surface. The rim surface may besubstantially perpendicular to the first surface and/or the secondsurface.

The monitor device coupling part may be provided at the rim surface,such as at a first part of the rim surface. For example, the monitordevice coupling part may be provided by an opening in the rim surface,such as in the first part of the rim surface.

The monitor device may comprise electronic circuitry, e.g. electroniccircuitry for receiving, processing, storing and/or transmitting signalsand/or data. The electronic circuitry may, for example, include aprocessor, a wireless communication unit, memory etc. The electroniccircuitry may be enclosed by the monitor device housing.

It is an advantage of the present disclosure that a user of a wounddressing, a caretaker or a health care professional is able to monitorand plan the use of the wound dressing. Communication of the operatingstates of the wound dressing is useful in helping to reduce the risk ofa user experiencing leakage from a wound dressing (e.g. exudate materialleakage from the wound dressing), which in turn helps in reducing risksof skin damage to a user and/or helps in providing improved healingconditions for the wound. In particular, determination and communicationof operating state according to the present disclosure is performedbased on monitor data indicative of a condition of the wound dressingwhich may not be visible to the user (because it is under the top layerof the wound dressing and/or inside the absorbent core layer). Thisresults in providing a clear distinction or differentiation betweendifferent degrees of exudation for different section or zones of thewound.

The present disclosure provides an efficient, and easy-to-use monitoringof a wound dressing system with a high degree of comfort for a userwhile allowing derivation of an operating state based on monitor datathat is not accessible or visible by the user or the health careprofessional. In other words, the disclosed method allows indication ofthe dynamic internal state of the wound dressing to a user, whichsupports the user in operating the wound dressing properly.

FIG. 1 illustrates an exemplary wound dressing system. The wounddressing system 1 comprises a wound dressing 2, 2A, 2B, a monitor device4, and optionally an accessory device 6 (mobile telephone). The monitordevice 4 is connectable to the wound dressing via respective interfacesof the monitor device 4 and wound dressing 2, 2A, 2B. The monitor device4 is configured for wireless communication with the accessory device 6.Optionally, the accessory device 6 is configured to communicate with aserver device 8 of the wound dressing system 1, e.g. via network 10. Theserver device 10 may be operated and/or controlled by the wound dressingmanufacturer and/or a service centre. Wound data and/or parameter databased on the wound data are obtained from electrodes/sensors of thewound dressing 2, 2A, 2B with the monitor device 4. The monitor device 4processes the wound data and/or parameter data based on the wound datato determine monitor data that are transmitted to the accessory device6. In the illustrated wound dressing system 1, the accessory device 6 isa mobile phone, however the accessory device 6 may be embodied asanother handheld device, such as a tablet device, or a wearable, such asa watch or other wrist-worn electronic device. Accordingly, the monitordevice 4 is configured to determine and transmit monitor data to theaccessory device 6.

FIG. 2 is a schematic block diagram of an exemplary monitor device. Themonitor device 4 comprises a monitor device housing 100, a processor101, and one or more interfaces, the one or more interfaces including afirst interface 102 (wound dressing interface) and a second interface104 (accessory interface). The monitor device 4 comprises a memory 106for storing wound data and/or parameter data based on the wound data.The memory 106 is connected to the processor 101 and/or the firstinterface 102. The first interface 102 is configured as a wound dressinginterface for electrically and/or mechanically connecting the monitordevice 4 to the wound dressing, e.g. wound dressing 2. The firstinterface 102 comprises a plurality of terminals for forming electricalconnections with respective terminals of the wound dressing. The firstinterface 102 comprises a first terminal 110, a second terminal 112 anda third terminal 114. The first interface 102 optionally comprises afourth terminal 116, a fifth terminal 118 and/or sixth terminal 119. Thefirst interface 102 of the monitor device 4 comprises a coupling part120 for forming a mechanical connection, such as a releasable coupling,between the monitor device 4 and the wound dressing. The coupling part120 and terminals 110, 112, 114, 116, 118, 119 of the first interface102 form (at least part of) a first connector of the monitor device 4.Terminals 110, 112, and 114 may be respectively coupled to firstelectrodes 210A, 210B, 210C via the monitor interface of the wounddressing, and terminals 116, 118, 119 may be respectively coupled tosecond electrodes 212A, 212B, 212C via the monitor interface of thewound dressing.

The monitor device 4 comprises a power unit 121 for powering the monitordevice and active components thereof, i.e. the power unit 121 isconnected to the processor 101, the first interface 102, the secondinterface 104, and memory 106. The power unit comprises a battery andoptionally charging circuitry. The charging circuitry is optionallyconnected to the battery and terminals of the first interface 102 forcharging the battery via terminals of the first interface, e.g.terminals of the first connector.

The second interface 104 of monitor device 4 is configured as anaccessory interface for connecting the monitor device 4 to one or moreaccessory devices such as accessory device 6. The second interface 104comprises an antenna 122 and a wireless transceiver 124 configured forwireless communication with accessory device(s). Optionally, the secondinterface 104 comprises a loudspeaker 126 and/or a haptic feedbackelement 128 for provision of respective audio signal and/or hapticfeedback to the user.

The monitor device 6 optionally comprises a sensor unit 140 connected tothe processor 101. The sensor unit 140 comprises a temperature sensorfor feeding temperature data to the processor and/or a G-sensor oraccelerometer for feeding acceleration data to the processor 101.

The processor 101 is configured to apply a processing scheme, and thefirst interface 102 is configured for collecting wound data from thewound dressing coupled to the first interface, the wound data comprisingwound data from sensor points (electrode pairs) of the wound dressing.The wound data may comprise first wound data WD_1 from a first electrodepair (first sensor point) of the wound dressing, second wound data WD_2from a second electrode pair (second sensor point) of the wounddressing, and third wound data WD_3 from a third electrode pair (thirdsensor point) of the wound dressing. In the illustrated monitor device,the processor is configured to collect, WD_1, WD_2, WD_3, . . . , WD_9from nine sensor points of the wound dressing formed by nine electrodepairs being combinations of a first electrode of the first set of firstelectrodes and a second electrode of the second set of secondelectrodes. The wound data may be stored in the memory 106 and/orprocessed in the processor 101 in order to obtain parameter data basedon the wound data. The parameter data may be stored in the memory 106.The processor 101 is configured to apply a processing scheme, wherein toapply a processing scheme comprises obtain first parameter data P_1including p_1_1 being the resistance between the two electrodes formingthe first sensor point based on the first wound data; obtain secondparameter data P_2 including p_2_1 being the resistance between the twoelectrodes forming the second sensor point based on the second wounddata; obtain third parameter data P_3 including p_3_1 being theresistance between the two electrodes forming the third sensor pointbased on the third wound data. In other words, the processor 101 isconfigured to obtain parameters p_1_1, p_2_1, . . . , p_9_1 beingresistances based on respective wound data WD_1, WD_2, . . . , WD_9obtained between the two electrodes forming the respective sensorpoints. To apply a processing scheme comprises to determine an operatingstate of the wound dressing based on one or more, e.g. all, of theparameter data P_1, P_2, . . . , P_9 including p_1_1, p_2_1, . . . ,p_9_1. The operating state is optionally indicative of a degree ofwetting or wetting pattern on the distal side of the absorbent corelayer of the wound dressing.

The monitor device 4 is optionally configured to, in accordance with adetermination that the operating state is a first operating state of thewound dressing, transmit a first monitor signal comprising monitor dataindicative of the first operating state of the wound dressing via thesecond interface, the monitor data optionally including including apattern representation of the wetting pattern and/or the degree ofwetting. The pattern representation may comprise a pattern typeidentifier and/or pattern data indicative of or comprising parameterdata. Optionally, the monitor device 4 may be configured to, inaccordance with a determination that the operating state is a secondoperating state of the wound dressing, transmit a second monitor signalcomprising monitor data indicative of the second operating state of thewound dressing via the second interface, the monitor data optionallyincluding including a pattern representation of the wetting patternand/or the degree of wetting. The pattern representation may comprise apattern type identifier and/or pattern data indicative of or comprisingparameter data.

FIG. 3 shows a proximal view of an exemplary first adhesive layer of thewound dressing. The first adhesive layer 150 has a proximal surface 150Aconfigured for attachment of the wound dressing to the skin surface of auser. The first adhesive layer has perforations or through-goingopenings 152 arranged within absorbing region 154 for allowing exudatefrom the wound to flow through the perforations of first adhesive layer150 to be absorbed by absorbent core layer arranged on the distal sideof the first adhesive layer.

FIG. 4 is a schematic cross-section of an exemplary wound dressing. Thewound dressing 2 comprises a first adhesive layer 150 with a proximalsurface 150A configured for attachment of the wound dressing to the skinsurface of a user. The wound dressing 2 may form part of wound dressingsystem 1. The wound dressing 2 comprises an absorbent core layer 202with a proximal surface 202A and a distal surface 202B; an electrodeassembly 204, 204A, 204B comprising a plurality of electrodes arrangedon a distal side of the absorbent core layer 202; and a top layer 206 atleast partly on a distal side of the electrode assembly. The wounddressing comprises a monitor interface 207 configured to connectelectrodes of the wound dressing to terminals of monitor device.

FIG. 5 is a proximal view of an exemplary and schematic electrodeassembly of wound dressing 2. The electrode assembly 204 comprises afirst support layer 208 and a plurality of electrodes printed on aproximal surface 208A of the first support layer, i.e. the plurality ofelectrodes is arranged on a distal side of the absorbent core layer ofthe wound dressing. 202. The plurality of electrodes comprises a firstset 210 of nine first electrodes 210A, . . . , 210I and a second set 212of a second electrode 212A. A sensing part of a first electrode and asensing part of a second electrode forms a sensor point. The electrodeassembly 204 comprises nine sensor points 214 arranged on the proximalsurface of the first support layer and distributed along a distalsurface of the absorbent core layer, e.g. as shown with nine sensorpoints arranged in a 3×3 matrix sensor point configuration.

The electrode assembly 204 comprises a first masking layer 216 coveringand isolating electrode parts of the first electrodes 210A, . . . , 210Iand the second electrode 212A. The first masking layer 216 is printed onthe first support layer/electrodes and comprises a number of sensorpoint openings to form respective sensor points of the electrodeassembly by exposing sensing parts of first electrodes 210A, . . . ,210I and second electrode 212A.

The second electrode 212A operates as a reference electrode (ground) forthe first electrodes 210A, . . . , 210I and forms a part of therespective sensor points 214 of electrode assembly 204. The sensorpoints 214 are arranged with a distance between two neighbouring sensorpoints in the range from 3 mm to 50 mm, e.g. with a center-to-centerdistance of 30 mm.

Each electrode 210A, . . . , 210I, 212 has a respective connection part(connection parts indicated with dashed box 215 for forming a connectionto monitor device via a wired or wireless monitor interface of the wounddressing.

FIG. 6 shows a more detailed view of a sensor point 214 of an electrodeassembly, e.g. electrode assembly 204, see dashed box in FIG. 5. Thesensor point 214 is formed by a first sensing part 218 of a firstelectrode and a second sensing part 220 of a second electrode. The firstsensing part 218 and the second sensing part 220 are exposed to theabsorbent core layer of the wound dressing through sensor point opening222 of the first masking layer 216. Thus, exudate or other fluidreaching the distal surface of the absorbent core layer short-circuitsthe first sensing part 218 and the second sensing part 220. In theillustrated electrode assembly, the sensor point opening 222 is circularwith a radius in the range from 2 to 10 mm.

FIG. 7 is a schematic cross-section of an exemplary wound dressing. Thewound dressing 2A comprises a first adhesive layer 150 with a proximalsurface 150A configured for attachment of the wound dressing to the skinsurface of a user. The wound dressing 2A may form part of wound dressingsystem 1. The wound dressing 2A comprises an absorbent core layer 202with a proximal surface 202A and a distal surface 202B; and an electrodeassembly 204A comprising a plurality of electrodes arranged on a distalside of the absorbent core layer 202, wherein the plurality ofelectrodes comprises a first set of first electrodes arranged on aproximal surface 208A and/or distal surface 208B of first support layer208. The electrode assembly 204A comprises a second support layer 224,and the plurality of electrodes comprises a second set of secondelectrodes arranged on a proximal surface and/or distal surface ofsecond support layer 208. The electrode assembly 204A comprises aspacing layer 226 arranged between the first support layer 208 and thesecond support layer 224. Further, a top layer 206 is arranged at leastpartly on a distal side of the electrode assembly 204A. The wounddressing 2A comprises a monitor interface 207A configured to connectelectrodes of the wound dressing to terminals of monitor device.

FIG. 8 shows a proximal view of an exemplary first support layer 208,e.g. of electrode assembly 204, electrode assembly 204A, electrodeassembly 204B. The electrode assembly comprises three first electrodes210A, 210B, 210C printed on the proximal surface 208A of the firstsupport layer 208, wherein each electrode 210A, 210B, 210C comprisesthree first sensing parts 218 exposed through respective sensor pointopenings of first masking layer, see FIG. 9. The first support layer 208has a plurality of sensor point openings 250 for allowing exudate topass through the first support layer (from proximal side to distal side)and reach sensing parts of second electrodes arranged on the distal sideor distal surface of the first support layer 208. Each sensor pointopening 250 is optionally centered in a respective first sensing part218 of a first electrode. Each first electrode 210A, 210B, and 210C hasa connection part 252 for connection to or forming part of a monitorinterface of the wound dressing. In one or more exemplary electrodeassemblies, e.g. electrode assemblies 204A, 204B shown in FIG. 7, thefirst electrodes 210A, 210B, 210C may be printed on the distal surface208B of the first support layer 208.

FIG. 9 shows a proximal view of an exemplary first masking layer 216 ofelectrode assembly with first support layer of FIG. 8. The first maskinglayer 216 is printed on the proximal surface/distal surface of firstsupport layer partly covering first electrodes 210A, 210B, and 210C ofthe electrode assembly. The first masking layer comprises nine sensorpoint openings 222 arranged to fit a 3×3 matrix sensor pointconfiguration and respectively aligned with first sensing parts 218 offirst electrodes 210A, 210B, 210C.

FIG. 10 shows a proximal view of an exemplary second support layer 224,e.g. of electrode assembly 204A. The electrode assembly comprises threesecond electrodes 212A, 212B, 212C printed on proximal surface 224A ofthe second support layer 224, wherein each electrode 212A, 212B, 212Ccomprises three second sensing parts 220 exposed through respectivesensor point openings of second masking layer, see FIG. 11. Optionally,the second support layer 224 has a plurality of sensor point openings254 for allowing exudate to pass through the second support layer (fromproximal side to distal side). Each sensor point opening 254 isoptionally centered in a respective second sensing part 220 of a secondelectrode. Each second electrode 212A, 212B, and 212C has a connectionpart 256 for connection to or forming part of a monitor interface of thewound dressing.

FIG. 11 shows a proximal view of an exemplary second masking layer 270of electrode assembly 204A. The second masking layer 270 is printed onthe proximal surface 224A of the second support layer 224 partlycovering second electrodes 212A, 212B, and 212C of the electrodeassembly. The second masking layer 270 comprises nine sensor pointopenings 272 arranged to fit a 3×3 matrix sensor point configuration andrespectively aligned with second sensing parts 220 of second electrodes212A, 212B, 212C. Referring back to FIGS. 7-11, the first sensing parts218 of first electrodes 210A, 210B, 210C are respectively aligned with asecond sensing part 220 of second electrodes 212A, 212B, 212C to formsensor points.

FIG. 12 shows a distal view of an exemplary second support layer 224,e.g. of electrode assembly 204B. The electrode assembly comprises threesecond electrodes 212A, 212B, 212C printed on distal surface 224B of thesecond support layer 224, wherein each electrode 212A, 212B, 212Ccomprises three second sensing parts 220 optionally exposed throughrespective sensor point openings of second masking layer, see FIG. 13.The second support layer 224 has a plurality of sensor point openings254 for allowing exudate to pass through the second support layer (fromproximal side to distal side) and reach second sensing parts 220 ofsecond electrodes arranged on the distal side or distal surface of thesecond support layer 224. Each sensor point opening 254 is optionallycentered in a respective second sensing part 220 of a second electrode.Each second electrode 212A, 212B, and 212C has a connection part 256 forconnection to or forming part of a monitor interface of the wounddressing.

FIG. 13 shows a proximal view of an exemplary and optional secondmasking layer 270A of electrode assembly 204B or a second masking layer270A of electrode assembly 204. The second masking layer 270A is printedon the distal surface 224B of the second support layer 224 or on distalsurface 208B of the first support layer 208 partly covering secondelectrodes 212A, 212B, and 212C of the electrode assembly. The secondmasking layer 270A comprises nine sensor point openings 272 arranged tofit a 3×3 matrix sensor point configuration and respectively alignedwith second sensing parts 220 of second electrodes 212A, 212B, 212C.Referring back to FIGS. 4 and 7-11, the first sensing parts 218 of firstelectrodes 210A, 210B, 210C are respectively aligned with a secondsensing part 220 of second electrodes 212A, 212B, 212C to form sensorpoints.

FIG. 14 shows a distal view of an exemplary first support layer 208 ofan electrode assembly, e.g. of electrode assembly 204. The electrodeassembly comprises three second electrodes 212A, 212B, 212C printed ondistal surface 224B of the first support layer 208, wherein each secondelectrode 212A, 212B, 212C comprises three second sensing parts 220optionally exposed through respective sensor point openings of secondmasking layer, see FIG. 13. The first support layer 208 has a pluralityof sensor point openings 250 for allowing exudate to pass through thefirst support layer (from proximal side to distal side) and reach secondsensing parts 220 of second electrodes arranged on the distal side ordistal surface of the first support layer 208. Each sensor point opening250 is optionally centered in a respective second sensing part 220 of asecond electrode. Each second electrode 212A, 212B, and 212C has aconnection part 256 for connection to or forming part of a monitorinterface of the wound dressing.

FIG. 15 illustrates a schematic cross-section of a part of a wounddressing comprising an exemplary monitor interface 207. The monitorinterface 207 comprises a number of terminals formed by connection parts252, 256 of first electrodes and second electrodes arranged on proximaland/or distal side of first support layer 208 of the electrode assembly.A first part 280 of electrode assembly 204 extends through a top layeropening 282 in the top layer 206 and outside the absorbent core layer202 when seen in radial direction R. The connection parts 252, 256 ofthe electrode assembly are external to the top layer 206 and formterminals of the monitor interface 207. The monitor interface 207comprises coupling part 284 attached to the electrode assembly 204 bygluing or welding of the coupling part 284 to the distal surface of thefirst support layer 208 and to the distal surface of the top layer 206.

FIG. 16 is a distal view of a part of a wound dressing with monitorinterface 207. The coupling part 284 comprises a first part 286 glued tothe first support layer and a second part 288 glued or welded to thedistal surface of the top layer 206.

FIG. 17 illustrates a schematic cross-section of a part of a wounddressing comprising an exemplary monitor interface 207A. The monitorinterface 207A comprises a number of terminals formed by connectionparts 252 of first electrodes arranged on the proximal surface of firstsupport layer 208 and connection parts 256 of second electrodes arrangedon the distal surface of the second support layer 224 of the electrodeassembly. The electrode assembly comprises a reinforcement element 290forming a part of the first part 280 of the electrode assembly. Thefirst part 280 extends through top layer opening 282 in the top layer206 and outside the absorbent core layer 202 when seen in radialdirection R. The monitor interface 207A comprises a coupling part 284welded to the distal surface of top layer and accommodating/supportingthe first part 280 including the reinforcement element 290 and at partof the support layers 208, 224.

A first part 280 of electrode assembly 204 extends through a top layeropening 282 in the top layer 206 and outside the absorbent core layer202 when seen in radial direction R. The connection parts 252, 256 ofthe electrode assembly are external to the top layer 206 and formterminals of the monitor interface 207. The monitor interface 207comprises coupling part 284 attached to the electrode assembly 204 bygluing or welding of the coupling part 284 to the distal surface of thefirst support layer 208 and to the distal surface of the top layer 206.The first part 280 of the electrode assembly extends into the couplingpart 284.

FIG. 18 is a distal view of a part of a wound dressing with monitorinterface 207A. The coupling part 284 is welded to the distal surface ofthe first support layer 206.

FIG. 19 illustrates a schematic cross-section of a part of an exemplarywound dressing. The wound dressing 2B comprises a top layer 206; a firstadhesive layer 150 with a proximal surface configured for attachment ofthe wound dressing to the skin surface of a user; an absorbent corelayer 150; an electrode assembly 204, 204A, 204B comprising a pluralityof electrodes arranged on a distal side of the absorbent core layer 202in a second part 281 of the electrode assembly; and a monitor interface207B configured for connecting the wound dressing to a monitor device,the monitor interface 207B comprising a coupling part 284 and aplurality of terminals 292 formed by connection parts of electrodes ofthe electrode assembly 204, 204A, 204B, wherein the terminals 292 areconfigured to form electrical connections with respective terminals ofthe monitor device. The wound dressing 2B comprises a flexible element294, the flexible element being bendable and/or twistable between afirst flexible element end 296 and a second flexible element end 298,wherein the coupling part 284 is positioned at the first flexibleelement end 296. The first part 280 of the electrode assembly at leastpartly forms the first flexible element 296. Optionally, a flexiblereinforcement element (not shown) forms a part of the flexible element.The reinforcement element (not shown) may be arranged on the distal sideand/or on the proximal side of the electrode assembly. The flexiblereinforcement element may be a sleeve.

The coupling part 284 is configured to engage with the monitor device bya linear motion in an engagement direction X_1 of the monitor devicerelative to the wound dressing. The engagement direction X_1 issubstantially parallel to a longitudinal direction of the flexibleelement at the first flexible element end.

Optionally, the wound dressing comprises a first attachment element 300,e.g. a hook or loop element, and/or a second attachment element 302 e.g.a hook or loop element, wherein the first attachment element 300 ispositioned near or at the first flexible element end 296, e.g. oncoupling part 284, and the second attachment element 302 extends on thedistal side 206B of the top layer, the first attachment element 300being configured to attach to the second attachment element 302.

FIG. 20 is a distal view of a part of wound dressing 2B with monitorinterface 207B.

FIG. 21 schematically illustrates a flexible element 294 and a couplingpart 284 (monitor interface) of a wound dressing, such as the wounddressing 2B. The coupling part 284 is positioned at a first flexibleelement end 296 of the flexible element 294. FIG. 21 also schematicallyillustrates a monitor device 4 for coupling with the wound dressing 2B.

The monitor device 4 and/or the wound dressing 2B comprises a lockingmechanism configured to lock the monitor device 4 in a coupled positionwith the wound dressing 2B.

The locking mechanism comprises a locking element 304. The lockingelement 304 is provided on the coupling part 284 of the wound dressing2B. However, in another exemplary monitor device and/or wound dressing,the locking element 304 may be provided on monitor device 4.

The locking element 304, in the illustrated example, comprises a sliderslidable in a first slider direction XS_1 and/or a second sliderdirection XS_2. The first slider direction XS_1 and the second sliderdirection XS_2 are, in the illustrated example, substantially parallelto the engagement direction X_1412 and the disengagement direction X_2.The locking element 304 is configured to unlock and/or lock the lockingmechanism, such as to unlock the monitor device 4 in the coupledposition with the wound dressing and/or to lock the monitor device 4 inthe coupled position with the wound dressing 2B. For example, slidingthe slider in the first slider direction XS_1 may unlock the monitordevice 4 in the coupled position with the wound dressing 2B, and slidingthe slider in the second slider direction XS_2 may lock the monitordevice 4 in the coupled position with the wound dressing 2B.Alternatively, the slider may be biased, e.g. spring loaded, towards thesecond slider direction XS_2, and sliding the slider in the first sliderdirection XS_1 may unlock the monitor device 4 in the coupled positionwith the wound dressing 2B. The monitor device 4 optionally comprises anattachment element (not shown, optionally arranged on proximal side ofmonitor device), such as a look or hook element, configured to attach tothe wound dressing, such as to attach to the second attachment elementof wound dressing. In one or more exemplary wound dressings, theattachment element of the monitor device is a button element to form abutton coupling with the second attachment element.

The use of the terms “first”, “second”, “third” and “fourth”, “primary”,“secondary”, “tertiary”, “quaternary”, “quinary” etc. does not imply anyparticular order, but are included to identify individual elements.Moreover, the use of the terms “first”, “second”, “third” and “fourth”,“primary”, “secondary”, “tertiary” etc. does not denote any order orimportance, but rather the terms “first”, “second”, “third” and“fourth”, “primary”, “secondary”, “tertiary” etc. are used todistinguish one element from another. Note that the words “first”,“second”, “third” and “fourth”, “primary”, “secondary”, “tertiary” etc.are used here and elsewhere for labelling purposes only and are notintended to denote any specific spatial or temporal ordering.Furthermore, the labelling of a first element does not imply thepresence of a second element and vice versa.

Although particular features have been shown and described, it will beunderstood that they are not intended to limit the claimed invention,and it will be made obvious to those skilled in the art that variouschanges and modifications may be made without departing from the spiritand scope of the claimed invention. The specification and drawings are,accordingly to be regarded in an illustrative rather than restrictivesense. The claimed invention is intended to cover all alternatives,modifications, and equivalents.

LIST OF REFERENCES

-   1 wound dressing system-   2, 2A, 2B wound dressing-   4 monitor device-   6 accessory device-   8 server device-   10 network-   100 monitor device housing-   101 processor 101-   102 first interface (wound dressing interface)-   104 second interface (accessory interface)-   106 memory-   110 first terminal-   112 second terminal-   114 third terminal-   116 fourth terminal-   118 fifth terminal-   119 sixth terminal-   120 coupling part-   121 power unit-   122 antenna-   124 wireless transceiver-   126 loudspeaker-   128 haptic feedback element-   140 sensor unit-   150 first adhesive layer-   150A proximal surface of the first adhesive layer-   152 perforations of first adhesive layer-   154 absorbing region-   202 absorbent core layer-   202A proximal surface of absorbent core layer-   202B distal surface of absorbent core layer-   204, 204A, 204B electrode assembly-   206 top layer-   207, 207A, 207B monitor interface-   208 first support layer-   208A proximal surface of first support layer-   208B distal surface of first support layer-   210 first set of first electrodes-   210A, 210B, 210C, 210D, 210E, 210F, 210G, 210G, 210I first electrode-   212 second set of second electrodes-   212A, 212B, 212C second electrode-   214 sensor point-   215 connection parts of plurality of electrodes-   216 first masking layer-   218 first sensing part of first electrode-   220 second sensing part of second electrode-   222 sensor point opening of first masking layer-   224 second support layer-   224A proximal surface of second support layer-   224B distal surface of second support layer-   226 spacing layer-   250 sensor point opening of first support layer-   252 connection point/part of first electrode-   254 sensor point opening of second support layer-   256 connection point/part of second electrode-   270, 270A second masking layer-   272 sensor point openings-   280 first part of electrode assembly-   281 second part of electrode assembly-   282 top layer opening-   284 coupling part-   286 first part of coupling part-   288 second part of coupling part-   290 reinforcement element-   292 terminals of monitor interface-   294 flexible element-   296 first flexible element end-   298 second flexible element end-   300 first attachment element-   302 second attachment element-   304 locking element-   X_1 engagement direction-   X_2 disengagement direction-   XS_1 first slider direction-   XS_2 second slider direction

1. A wound dressing comprising: a top layer; a first adhesive layer witha proximal surface configured for attachment of the wound dressing tothe skin surface of a user; an absorbent core layer; an electrodeassembly comprising a plurality of electrodes arranged on a distal sideof the absorbent core layer; and a monitor interface configured forconnecting the wound dressing to a monitor device, the monitor interfacecomprising a plurality of terminals configured to form electricalconnections with respective terminals of the monitor device, wherein thewound dressing comprises a flexible element, the flexible element beingbendable and/or twistable between a first flexible element end and asecond flexible element end, and wherein the monitor interface comprisesa coupling part positioned at the first flexible element end.
 2. Wounddressing according to claim 1, wherein a first part of the top layer anda first part of the electrode assembly at least partly forms the firstflexible element.
 3. Wound dressing according to any of claims 1-2,wherein the coupling part is configured to engage with the monitordevice by a linear motion in an engagement direction of the monitordevice relative to the wound dressing.
 4. Wound dressing according toclaim 3, wherein the engagement direction is substantially parallel to alongitudinal direction of the flexible element at the first flexibleelement end.
 5. Wound dressing according to any of claims 1-4, whereinthe wound dressing comprises a locking mechanism configured to lock themonitor device in a coupled position with the wound dressing.
 6. Wounddressing according to claim 5, wherein the locking mechanism is biasedtowards locking of the locking mechanism
 7. Wound dressing according toany of claims 5-6, wherein the locking mechanism comprises a lockingelement configured to unlock and/or lock the locking mechanism upon userinteraction with the locking element.
 8. Wound dressing according toclaim 7 as dependent on claim 3, wherein the locking element comprises afirst button being deflectable in a first direction, wherein the firstdirection is substantially perpendicular to the engagement direction. 9.Wound dressing according to claim 7, wherein the locking elementcomprises a first button and a second button, the first button beingdeflectable in a first direction and the second button being deflectablein a second direction, wherein the first direction is substantiallyopposite the second direction.
 10. Wound dressing according to claim 9as dependent on claim 3, wherein the first direction and the seconddirection are substantially perpendicular to the engagement direction.11. Wound dressing according to any of claims 7-10, wherein the lockingelement comprises a slider being slidable in a first slider direction,and wherein the slider is spring loaded and biased towards a secondslider direction, wherein the first slider direction is opposite thesecond slider direction.
 12. Wound dressing according to claim 11 asdependent on claim 3, wherein the first slider direction and the secondslider direction are substantially parallel to the engagement direction.13. Wound dressing according to any of the preceding claims, the wounddressing comprising a first attachment element and a second attachmentelement, wherein the first attachment element is positioned at the firstflexible element end and the second attachment element extends on thedistal side of the top layer, the first attachment element beingconfigured to attach to the second attachment element.
 14. Wounddressing according to claim 13, wherein the first attachment element isin the form of a clamp configured to clamp to the second attachmentelement.
 15. Wound dressing according to claim 13, wherein the firstattachment element and the second attachment element form ahook-and-loop coupling.
 16. Wound dressing according to claim 13,wherein the first attachment element and the second attachment elementform a magnetic coupling.
 17. Wound dressing according to any of claims1-16, wherein the coupling part is configured for forming a mechanicalconnection, such as a releasable coupling, between the monitor deviceand the wound dressing.
 18. A monitor device for connecting to a wounddressing, the monitor device comprising: a monitor device housing;electronic circuitry; and a wound dressing interface configured forconnecting the monitor device to the wound dressing, the wound dressinginterface comprising a plurality of terminals for connecting with aplurality of electrodes of the wound dressing, the wound dressinginterface comprising a monitor device coupling part configured forcoupling between the monitor device and the wound dressing, wherein themonitor device comprises an attachment element configured to attach tothe wound dressing.
 19. Monitor device according to claim 18, whereinthe attachment element is in the form of a clamp configured to clamp toan attachment element of the wound dressing.
 20. Monitor deviceaccording to claim 18, wherein the attachment element is in the form ofa slit configured to receive an attachment element of the wounddressing.
 21. Monitor device according to claim 18, wherein theattachment element is in the form of a hook element or a loop elementconfigured to engage in a hook and loop coupling with the wounddressing.
 22. Monitor device according to claim 18, wherein theattachment element is in the form of a magnetic material configured tomagnetically attach to an attachment element of the wound dressing. 23.Monitor device according to any of claims 18-22, wherein the monitordevice coupling part is configured to engage with the wound dressing bya linear motion in an engagement direction of the monitor devicerelative to the wound dressing.
 24. Monitor device according to any ofclaims 18-23, the monitor device comprising a locking mechanismconfigured to lock the monitor device in a coupled position with thewound dressing.
 25. Monitor device according to claim 24, wherein thelocking mechanism is biased towards locking of the locking mechanism.26. Monitor device according to any of claims 24-25, wherein the lockingmechanism comprises a locking element configured to unlock or lock thelocking mechanism upon user interaction with the locking element. 27.Monitor device according to claim 25 as dependent on claim 23, whereinthe locking element comprises a first button being deflectable in afirst direction, wherein the first direction is substantiallyperpendicular to the engagement direction.
 28. Monitor device accordingto claim 27, wherein the locking element comprises a first button and asecond button, the first button being deflectable in a first directionand the second button being deflectable in a second direction, whereinthe first direction is substantially opposite the second direction. 29.Monitor device according to claim 28 as dependent on claim 23, whereinthe first direction and the second direction are substantiallyperpendicular to the engagement direction.
 30. Monitor device accordingto any of claims 26-29, wherein the locking element comprises a sliderbeing slidable in a first slider direction, and wherein the slider isspring loaded and biased towards a second slider direction, wherein thefirst slider direction is opposite the second slider direction. 31.Monitor device according to claim 30 as dependent on claim 23, whereinthe first slider direction and the second slider direction aresubstantially parallel to the engagement direction.